Roche/Ventana: cobas CMV molecular diagnostic for cytomegalovirus (June 1/Original PMA); Ventana PD-L1 (SP263) Assay (May 1/ Original PMA); CINtec Histology test (March 4)
Abbott Laboratories/St. Jude Medical: ABBOTT REALTIME CMV assay(May 18; Original); MRI-conditional pacemakers and leads (Assurity MRI, Endurity MRI, Tendril MRI Lead, MRI Activator Merlin PCS programmer software) (Jan. 31/Original)
Biotronik: Astron Pulsar/Pulsar-18 stent system (March 23/Original); Pro-Kinetic Energy cobalt chromium coronary stent (Feb. 14/Original)
Medtronic: Resolute Onyx drug-eluting coronary stent(April 28/Original); Melody, Ensemble, Ensemble IItranscatheter pulmonary valve system (Feb. 24/Panel-Track Supplement)
Edwards Lifesciences: Edwards Pericardial Aortic Bioprosthesis(June 29/Original); Sapien 3 transcatheter aortic heart valve system (June 5/Panel-Track)
CR Bard: Lifestreamballoon expandable vascular covered stent (April 24/Original); Lutonix 035 drug-coated balloon catheter (Feb. 7/Panel-Track)

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